308 Federal Register / Vol. 78, No. 2 / Thursday, January 3, 2013 / Notices 

The evaluation and reporting process 

is necessary to ensure that CDC receives 

standardized, accurate, thorough 

evaluation data from both health 

department and CBO grantees. For these 

reasons, CDC developed standardized 

NHM&E variables through extensive 

consultation with representatives from 

health departments, CBOs, and national 

partners (e.g., The National Alliance of 

State and Territorial AIDS Directors, 

Urban Coalition of HIV/AIDS 

Prevention Services, and National 

Minority AIDS Council). 

CDC requires CBOs and health 

departments who receive federal funds 

for HIV prevention to report nonidentifying, client-level and aggregatelevel, standardized evaluation data to: 

(1) Accurately determine the extent to 

which HIV prevention efforts are carried 

out, what types of agencies are 

providing services, what resources are 

allocated to those services, to whom 

services are being provided, and how 

these efforts have contributed to a 

reduction in HIV transmission; (2) 

improve ease of reporting to better meet 

these data needs; and (3) be accountable 

to stakeholders by informing them of 

HIV prevention activities and use of 

funds in HIV prevention nationwide. 

CDC HIV prevention program grantees 

will collect, enter or upload, and report 

agency-identifying information, budget 

data, intervention information, and 

client demographics and behavioral risk 

characteristics with an estimate of 

200,846 burden hours. Data collection 

will include searching existing data 

sources, gathering and maintaining data, 

document compilation, review of data, 

and data entry or upload into the webbased system. 

There are no additional costs to 

respondents other than their time. The 

total estimated annual burden hours are 

206,226. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Health jurisdictions .......................................... Agency Data ................................................... 69 2 1377 

HE/RR Data .................................................... 69 2 67 

HIV Testing Data ............................................ 69 2 1,229 

NEM&E Data Training .................................... 69 2 52 

Community-based Organizations ................... Agency Data ................................................... 200 2 30/60 

HE/RR Data .................................................... 200 2 20 

NHM&E Data Training .................................... 200 2 20 

Dated: December 27, 2012. 

Ron A. Otten, 

Director, Office of Scientific Integrity (OSI), 

Office of the Associate Director for Science 

(OADS), Office of the Director, Centers for 

Disease Control and Prevention. 

[FR Doc. 2012–31599 Filed 1–2–13; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3278–NC] 

Medicare Program; Request for 

Information on Hospital and Vendor 

Readiness for Electronic Health 

Records Hospital Inpatient Quality 

Data Reporting 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Request for information. 

SUMMARY: This document is a request for 

information from hospitals, electronic 

health record (EHR) vendors, and other 

interested parties regarding hospital 

readiness beginning calendar year 2014 

discharges to electronically report 

certain patient-level data under the 

Hospital Inpatient Quality Reporting 

(IQR) Program using the Quality 

Reporting Document Architecture 

(QRDA) Category I. 

DATES: The information solicited in this 

document must be received at the 

address provided below, no later than 5 

p.m. eastern standard time (e.s.t.) on 

January 22, 2013. 

ADDRESSES: In commenting, refer to file 

code CMS–3278–NC. Because of staff 

and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address only: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3278–NC, P.O. Box 8013, 

Baltimore, MD 21244–8013. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address only: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3278–NC, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments ONLY to the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, call 

telephone number (410) 786–9994 in 

advance to schedule your arrival with 

one of our staff members. 

Comments erroneously mailed to the 

addresses indicated as appropriate for 

hand or courier delivery may be delayed 

and received after the comment period. 


emcdonald on DSK67QTVN1PROD with 
Federal Register / Vol. 78, No. 2 / Thursday, January 3, 2013 / Notices 309 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Maria Harr, (410) 786–6710. 

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

We are interested in increasing 

efficiency and reducing the burden 

associated with hospital collection and 

submission of patient-level data on 

clinical quality measures (CQMs) and 

are exploring ways that hospitals might 

be able to report data on a subset of 

Hospital Inpatient Quality Reporting 

(IQR) Program measures specified under 

section 1886(b)(3)(B)(viii) of the Social 

Security Act (the Act) using the same 

certified electronic health record 

technology (CEHRT) that is used for 

reporting under the Electronic Health 

Record (EHR) Incentive Program as 

authorized by section 4102 of the 

American Recovery and Reinvestment 

Act of 2009 (ARRA). The goals of 

aligning quality measurement and 

reporting among our quality reporting 

programs are all of the following: 

• Streamline our quality reporting 

programs through automatic collection 

and reporting of data on CQMs using 

CEHRT. 

• Reduce burden to hospitals by 

allowing them to use EHRs to submit 

data on CQMs that are adopted for both 

the Hospital IQR Program and the EHR 

Incentive Program. 

• Develop a single set of electronic 

specifications for CQMs adopted under 

multiple quality reporting programs. 

• Support quality care improvement. 

• Adopt data standards to facilitate 

hospitals’ capturing, transmitting, and 

formatting data elements consistently 

and clearly. 

The Health Information Technology 

for Economic and Clinical Health 

(HITECH) Act, part of the American 

Recovery and Reinvestment Act of 2009 

(ARRA, Pub. L. 111–5), authorized 

Medicare and Medicaid incentive 

payments to eligible professionals and 

eligible hospitals when they adopt and 

meaningfully use CEHRT, as well as 

payment adjustments under Medicare 

beginning in 2015 for failure to 

demonstrate meaningful use. We have 

promulgated regulations establishing 

the criteria for Stage 1 and Stage 2 of 

meaningful use. More than 120,000 

eligible health care professionals and 

more than 3,300 hospitals have 

qualified to participate in the program 

and receive an incentive payment since 

it began in January 2011. 

The EHR Incentive Program Stage 2 

final rule (77 FR 53968) outlines our 

commitment to aligning quality 

measurement and reporting programs, 

including the Hospital IQR program, the 

Physician Quality Reporting System 

(PQRS), the Children’s Health Insurance 

Program (CHIP), and the Pioneer 

Accountable Care Organization (ACO) 

Model. The automatic collection and 

reporting of data elements for many 

measures through CEHRT is expected to 

greatly simplify reporting for various 

quality reporting programs. We envisage 

that hospitals will be able to switch 

primarily to EHR-based reporting of 

clinical quality data for many measures 

that are currently manually chartabstracted and submitted to CMS for the 

Hospital IQR Program. 

The Hospital IQR Program (http:// 

www.qualitynet.org/dcs/

ContentServer?cid=113811

5987129&pagename=Qnet

Public%2FPage%2FQnetTier

2&c=Page), which is authorized by 

section 1886(b)(3)(B)(viii) of the Act, is 

intended to equip patients with hospital 

quality of care information to make 

informed decisions about healthcare 

options and is also intended to 

encourage hospitals and clinicians to 

improve the quality of inpatient care 

provided to all patients. Hospital IQR 

Program data is available to consumers 

on the Hospital Compare Web site 

(http://www.hospitalcompare.hhs.gov/). 

Under the Hospital IQR Program, 

subsection (d) hospitals report data on 

selected quality measures to CMS. In 

selecting measures for the program, we 

strive to be consistent with the priorities 

identified in the National Quality 

Strategy. Subsection (d) hospitals report 

quality measures of process, structure, 

outcomes, patient perspectives on care, 

and efficiency that relate to services 

furnished in an inpatient acute care 

hospital setting in order to receive the 

full annual payment update (APU). 

Sections 1886(b)(3)(B)(viii)(I) of the Act 

states that the applicable percentage 

increase, for FY 2007 and each 

subsequent fiscal year, shall be reduced 

by 2.0 percentage points (or, beginning 

with FY 2015, by one-quarter of such 

applicable percentage increase 

(determined without regard to sections 

1886(b)(3)(B)(ix), (xi), or (xii) of the 

Act)) for any subsection (d) hospital that 

does not submit quality data in a form 

and manner, and at a time, specified by 

the Secretary. 

II. Solicitation for Information 

We are soliciting information from 

hospitals, EHR vendors, and other 

interested parties on a variety of subject 

matters. 

The following questions are intended 

for all hospitals, EHR vendors, and other 

interested parties: 

• How do hospitals and vendors 

perceive the alignment of EHR-based 

reporting and hospital quality reporting 

programs? What are the foreseen 

benefits and challenges? 

• Do hospitals and vendors envision 

being able to meet the criteria for 

reporting clinical quality measures 

electronically for the EHR Incentive 

Program as set forth in the EHR 

Incentive Program—Stage 2 final rule 

(77 FR 53968) and any related guidance 

issued? If not, what are the issues in 

meeting the requirements and what 

additional information is needed? 

We are specifically soliciting 

comments from hospitals and other 

interested parties on the following 

topics: 

• Is the hospital planning to adopt 

EHR technology that has been certified 

to the 2014 Edition EHR certification 

criteria during or before calendar year 

(CY) 2014? 

• Is the hospital aware of the payment 

adjustments authorized under the 

HITECH Act beginning in FY 2015 for 

failing to demonstrate meaningful use 

under the Medicare EHR Incentive 

Program? 

• Is the hospital planning to 

electronically report CQM data— 

specifically venous thromboembolism 

(VTE) and stroke (STK) and emergency 

department (ED) measures—under the 

Medicare EHR Incentive Program in FY 

2014? 

• Is the hospital already participating 

in or planning to participate in the 2013 

Medicare EHR Incentive Program 

Electronic Reporting Pilot for Eligible 

Hospitals and Critical Access Hospitals 


emcdonald on DSK67QTVN1PROD with 
310 Federal Register / Vol. 78, No. 2 / Thursday, January 3, 2013 / Notices 

(CAHs) (‘‘Pilot’’)? The pilot provides 

eligible hospitals and CAHs with an 

opportunity to meet the CQM reporting 

requirements of the Medicare EHR 

Incentive Program through electronic 

submission of CQM data. The pilot is a 

voluntary electronic reporting method 

used to satisfy the CQM reporting 

requirements for the Medicare EHR 

Incentive Program. If not, what barriers 

prevent the hospital from participating? 

• Does the hospital plan to report 

data leveraging any state health 

information exchange (HIE) initiative? 

• Does the hospital plan to report 

data leveraging the Nationwide Health 

Information Network (NwHIN) 

Exchange, which is now the eHealth 

Exchange? 

• Will the hospital use a third party 

to report quality data required under the 

EHR Incentive Program? 

• Are there operational challenges to 

electronically reporting quality data? If 

so, does the hospital have mitigation 

plans to overcome these challenges? 

• Has the hospital chief information 

officer (CIO) and/or chief operating 

officer (COO) prioritized electronically 

reporting quality data over the next 3 

years (2013 through 2015)? 

• Are there any evaluation or data 

validation methodologies that have been 

used by the hospital to assess the 

accuracy and reliability of clinical 

process of care quality data using QRDA 

category I standards? 

• What barriers and opportunities 

would be created by including sampling 

criteria for electronically reported 

measures under the EHR Incentive 

Program? 

We are specifically soliciting 

comments from EHR vendors and other 

interested parties in the following areas: 

• Is the EHR vendor’s technology 

currently certified under the Office of 

the National Coordinator for Health 

Information Technology (ONC) Health 

Information Technology (HIT) 

Certification Program to the 2001 

Edition EHR Certification Criteria? Does 

the vendor intend to have its EHR 

technology certified to the 2014 Edition 

EHR Certification Criteria? If so, when? 

• What are the top three operational 

challenges facing EHR vendors over the 

next 3 years (2013 through 2015)? Of 

those identified, does the EHR vendor 

have mitigation plans to overcome these 

challenges? 

• Are there any evaluation or data 

validation methodologies that have been 

used to assess the accuracy and 

reliability of clinical process of care 

quality data using QRDA category I 

standards? 

• Have vendors included random 

sampling functionalities in currently 

certified systems? If yes, what guidance 

for random sampling has been 

employed, if any? If no, what barriers 

are presented by adding this 

functionality to your currently certified 

systems? 

III. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this request for information, and, when 

we proceed with a subsequent 

document, we will respond to the 

comments in that document. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: December 21, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–31582 Filed 12–28–12; 11:15 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–1256] 

Draft Revision of Guidance for Industry 

on Providing Regulatory Submissions 

in Electronic Format—Certain Human 

Pharmaceutical Product Applications 

and Related Submissions Using the 

Electronic Common Technical 

Document Specifications; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of draft guidance for 

industry entitled ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Certain Human Pharmaceutical Product 

Applications and Related Submissions 

Using the eCTD Specifications.’’ The 

draft guidance announced in this notice 

is being issued in accordance with the 

Food and Drug Administration Safety 

and Innovation Act (FDASIA) which 

amended the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) to require 

that certain submissions under the 

FD&C Act and Public Health Service Act 

(PHS Act) be submitted in electronic 

format, beginning no earlier than 2 years 

after publication of the final version of 

the draft guidance. The draft guidance 

describes how FDA plans to implement 

the requirements for the electronic 

submission of applications for certain 

human pharmaceutical products and is 

being issued for public comment. In its 

final form, this document will also 

supersede the guidance titled 

‘‘Guidance for Industry Providing 

Regulatory Submissions in Electronic 

Format—Human Pharmaceutical 

Product Applications and Related 

Submissions Using the eCTD 

Specifications’’ that was issued in 

October 2005 and revised in April 2006 

and June 2008. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by March 4, 2013. 

ADDRESSES: Submit written requests for 

single copies of the documents to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 

Silver Spring, MD 20993–0002 or the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 1401 

Rockville Pike, Suite 200N, Rockville, 

MD 20852–1448. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the documents. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT:

Virginia Hussong, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 1161, 

Silver Spring, MD 20993, email: 

virginia.hussong@fda.hhs.gov; 

or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, Suite 200N, Rockville, 

MD 20852, 301–827–6210. 

SUPPLEMENTARY INFORMATION:

I. Background 

The electronic Common Technical 

Document (eCTD) is an International 

Conference on Harmonisation (ICH) 

standard based on specifications 


emcdonald on DSK67QTVN1PROD with